{"doc_desc":{"title":"Cohorte ANRS CO 21","idno":"FRESH-PEF73422-fr","producers":[{"name":"Faroudy BOUFASSA","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73422-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73422"},{"agency":"FReSH","code":"FRESH-PEF73422"}]},"title":"Cohorte ANRS CO 21","alternate_title":"CODEX"},"study_authorization":{"agency":[{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Faroudy;BOUFASSA","PILabo":"INSERM \/ Epid\u00e9miologie","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"278864074","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76","role":"sponsor id"},{"title":"SIREN","uri":"180089385","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76"},{"title":"SIREN","uri":"180089385"}]}]},"distribution_statement":{"contact":[{"name":"Olivier;LAMBOTTE","email":"olivier.lambotte@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[],"topics":[{"topic":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"Maladie par le virus de l'immunod\u00e9ficience humaine sans mention de tuberculose ni de paludisme","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1508081745","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Chez les patients VIH-1 positif asymptomatiques depuis au moins 5 ans apr\u00e8s infection par le VIH en absence de traitement antir\u00e9troviral, qu\u2019ils r\u00e9pondent aux d\u00e9finitions de patients ALT et\/ou HIC ainsi que chez les patients sous traitement antir\u00e9troviral et en \u00ab contr\u00f4le apr\u00e8s arr\u00eat de traitement antir\u00e9troviral \u00bb, \u00e9tudier leur \u00e9volution clinique et immuno-virologique et d\u00e9finir les param\u00e8tres du virus et de l\u2019h\u00f4te associ\u00e9s \u00e0 la non-progression de l\u2019infection.","abstract":"","coll_dates":[{"start":"2009-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        },\n        {\n            \"value\": \"Autre\",\n            \"concept\": {\n                \"vocab\": [],\n                \"vocabURI\": []\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Des sujets \u00ab ALT \u00bb : sujets Asymptomatiques \u00e0 Long Terme : sujets VIH-1-s\u00e9ropositifs depuis au moins 8 ans ayant un taux de lymphocytes CD4+ sup\u00e9rieur \u00e0 600\\\/mm3 et stable ou en augmentation (pente positive ou nulle) sur au minimum 3 examens cons\u00e9cutifs r\u00e9alis\u00e9s durant les 5 derni\u00e8res ann\u00e9es quelle que soit la charge virale en absence de traitement antir\u00e9troviral. Des sujets \u00ab HIC (HIV Controllers) \u00bb : sujets s\u00e9ropositifs pour le VIH-1 depuis au moins 5  ans, asymptomatiques, avec les 5 derni\u00e8res charges virales en ARN-VIH plasmatique cons\u00e9cutives < 400 copies\\\/mL quel que soit le taux de CD4 + en absence de traitement antir\u00e9troviral. Des sujets \u00ab ALT-HIC \u00bb : sujets r\u00e9pondant \u00e0 la double d\u00e9finition ALT et HIC c\u2019est \u00e0 dire des sujets VIH-1 s\u00e9ropositifs depuis au moins 8 ans et taux de lymphocytes CD4+ sup\u00e9rieur \u00e0 600\\\/mm3 avec un taux stable ou en augmentation (pente positive ou nulle) sur au minimum 3 examens cons\u00e9cutifs r\u00e9alis\u00e9s durant les 5 derni\u00e8res ann\u00e9es et avec les 5 derni\u00e8res charges virales en ARN-VIH plasmatique cons\u00e9cutives < 400 copies\\\/mL. Des sujets en \u00ab contr\u00f4leurs post-traitement \u00bb (ou post-treatment controllers, PTC) : sujets ayant eu une charge virale en ARN-VIH plasmatique > 2000 copies\\\/mL avant l\u2019initiation d\u2019un traitement antir\u00e9troviral que ce soit en primo-infection ou en phase chronique et dont le traitement a \u00e9t\u00e9 maintenu pendant au moins 12 mois; chez qui, une fois le traitement antir\u00e9troviral arr\u00eat\u00e9, la charge virale est rest\u00e9e < 400 copies\\\/mL pendant plus de 12 mois avec une exception pour un blip (une charge virale plasmatique au-dessus de  400 copies\\\/mL) encadr\u00e9 par deux charges virales < 400 copies\\\/mL. La derni\u00e8re charge virale plasmatique au moment de l\u2019inclusion devra, dans tous les cas, \u00eatre < 400 copies\\\/mL. \",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"346"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Mise a disposition des donn\u00e9es apr\u00e8s validation d&#x27;un projet de recherche par le Conseil Scientifique de la cohorte.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"Format des donn\u00e9es sur tables (SAS, Excel, Stata)."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"12-02-2020","lastUpdatedAuto":null,"lastUpdatedManual":"29-10-2020","isContributorPI":"Non","contributorName":"Olivier LAMBOTTE","contributorAffiliation":"UNIVERSITE PARIS-SACLAY","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France enti\u00e8re et DOM-TOM"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}